Combined intracranial and intravenous NK cell therapy for malignant brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, open-label investigator-initiated trial gives autologous ex vivo–expanded and activated NK cells both directly into the brain and intravenously to adults with malignant solid brain tumors who have progressed after standard treatments. The study uses a dose-escalation design to determine the maximum tolerated dose or maximum feasible dose of the combined intracranial and IV NK-cell regimen. Secondary measures include preliminary anti-tumor activity by progression-free and overall survival, objective response per RANO criteria, and immunologic changes in the tumor microenvironment and peripheral blood. Safety, tolerability, and feasibility endpoints will guide whether further development is warranted.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, age 18-70 years old (both ends included)
2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment
3. Karnofsky Performance Status (KPS) ≥ 60%
4. Life expectancy \> 4 weeks, and must be able to undergo an MRI with contrast
5. Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)
6. Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered
7. Must have adequate organ and marrow function as defined below:

   * White blood cell count (WBC) ≥ 3 x 10\^9/L
   * Absolute neutrophil count (ANC) \> 1 x 10\^9/L
   * Hemoglobin (Hb) ≥ 90 g/L
   * Platelet (PLT) ≥ 80×10\^9/L
   * Albumin transaminase (ALT) \& albumin transaminase (AST) \< 1.5 × institutional upper limit of normal (ULN)
   * Serum creatinine (Cr) \< 1.5 x institutional ULN
   * Total bilirubin \< 1.5 x institutional ULN
   * PT \& PTT ≤ 1.25 x institutional ULN
8. No obvious hereditary diseases
9. Normal cardiac function with left ventricular ejection fraction \>55%
10. No bleeding and coagulation disorders
11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and/or there aren't any indications of meningitis
12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
13. Signed, written informed consent

Exclusion Criteria:

1. Active hepatitis B or C virus, HIV infection, or other untreated active infection
2. Pregnant and lactating women
3. Participants with organ failure
4. Participants with a chronic disease requiring immunologic or hormonal therapy
5. Participants with an allergy to immunotherapy and related cells
6. Participants with uncontrolled intercurrent illness
7. Participants with psychiatric illness/social situations that would limit compliance with study requirements
8. Participants with a history of organ transplantation or who are awaiting organ transplantation

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhengzhou Second Hospital
  Zhengzhou, Henan, China Recruiting
• Henan Academy of Innovations in Medical Science
  Zhengzhou, Henan, China Recruiting
• Qinhuangdao Runze Hospital
  Qinhuangdao, Hebei, China Not yet recruiting

Study contacts

• Study coordinator: Chenlong YANG, M.D., Ph.D.
• Email: vik.yang@pku.edu.cn
• Phone: (+86)-135-1108-7060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.